MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM SIZE E RIGHT; PROSTHESIS, KNEE

Catalog Number	00588001502
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00588001502 fem size e right lot# 65577833.00599003523 ng 15mm dist only fem augm sze lot# 64574554.00599003524 20mm distal only fem aug sz e lot# 63251030.00598802011 11mm dia 100mm length offset stem ext 145mm lot# 63988012.00545001831 trabecular metal femoral diaphyseal cone, 30mm, m, rt lot# 64800341.00588005012 12mm height size e articular surface with hinge post lot# 65532680.00801102024 allen medullary cement plugs 1- 24mm dia, flange/12 mm dia lot# 65626531.G2: australia.H6: suggested code (annex g)- mechanical (g04) - femur.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient was revised for femoral loosening two years, three months post implantation.Attempts have been made and no additional information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b2; b5; b7; d2a; d2b; e1; g1; g3; h1; h2; h3; h4; h6.The following sections were updated: h6; h11.The reported event could not be confirmed due to lack of product.No product was returned.A photograph of the reported device was provided however the device failure could not be confirmed from the image.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The device history record was reviewed and no discrepancies relevant to the reported event were found.Stem pn 00598802011, ln 63988012.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.A definitive root cause cannot be determined.

• Brand Name: FEM SIZE E RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23417828
• Report Number: 0001822565-2025-03896
• Device Sequence Number: 10300120
• Product Code: JWH
• UDI-Device Identifier: 00889024199156
• UDI-Public: (01)00889024199156(17)271010(10)65577833
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00588001502
• Device Lot Number: 65577833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male